Bexa Pressure Mapping System

Basic Information

• Brand Name: Bexa Pressure Mapping System
• Primary DI: 00860000501729
• Version / Model: 1885
• Company Name: SURE INC.
• Labeler DUNS: 116944848
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-28
• Public Version: 1
• Public Version Date: 2021-11-05
• Public Version Status: New
• Public Device Record Key: d03c2045-36b0-4a12-826e-715cd552c254

Device Description

Breast lesion documentation system

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NKA	System, Documentation, Breast Lesion	Obstetrics/Gynecology	884.2990	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57820	Electronic clinical breast examination system	A portable assembly of devices designed to electronically measure, map, document and store information about breast lesions/masses with regard to shape, size, location, consistency/relative hardness during a clinical breast examination (CBE). It is typically used by physicians/clinical practitioners that perform CBE during breast cancer screening and evaluation of suspected breast masses. It typically consists of a hand-held applicator (tactile receptor containing pressure transducers), a portable computer, application software, and a calibrator. Scanning is performed over the entire breast or an area of interest and is typically displayed as a colour map differentiating the tissues.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860000501729	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K181672	000